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โ† Trials
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Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

RecruitingPhase 2, Phase 3Ages 18 Years - 100 YearsAllNational Institute of Diabetes and Digestive and โ€ฆ
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In plain words

What the trial is, and whether it could suit you

Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands. Objective: To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands. Eligibility: People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland. Design: Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples. Participants will have a 4-dimensional computed tomography (4D-CT) scan

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Aged 18-100 years old 2. Willing to have parathyroidectomy at NIH Clinical Center 3. Meets one of the following: 1. Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy. 2. Diagnosed with any forms of heritable primary hyperparathyroidism (index presentation or recurrent disease) and is a potential candidate for parathyroidectomy. Participants clinically suspected of multi-gland disease (individuals with secondary/tertiary hyperparathyroidism) or germline predisposition PHPT syndrome are included in this cohort 3. Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy or lactation 2. Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical. 3. For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery 4. Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan. 5. Unable or unwilling to provide informed consent. 6. Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
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What it tests

  • 18F-FCH
  • NeuroEXPLORER
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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